PATH

Senior Data Management Specialist, CVIA Clinical Affairs Office

PATH is an international organization that drives transformative innovation to save lives and improve health, especially among women and children. We accelerate innovation across five platforms-vaccines, drugs, diagnostics, devices, and system and service innovations-that harness our entrepreneurial insight, scientific and public health expertise, and passion for health equity. By mobilizing partners around the world, we take innovation to scale, working alongside countries primarily in Africa and Asia to tackle their greatest health needs. Together, we deliver measurable results that disrupt the cycle of poor health.

PATH’s Center for Vaccine Innovation and Access brings together our expertise across every stage of the long and complex process of vaccine research, development, and delivery to make lifesaving vaccines widely available to children and communities across the world. CVIA’s current portfolio encompasses more than two dozen vaccines either in development or already in use to protect against 15 different diseases. Our focus is on vaccines to address the leading diseases that claim children’s lives worldwide: pneumonia, diarrheal disease, and malaria; as well as other global health priorities, such as polio and meningitis. We work in partnership with national health ministries, pharmaceutical manufacturers, donors, international financing and regulatory organizations, and many others.

PATH’s CVIA conducts vaccine development and associated technology research and vaccine introduction activities in the following disease areas: malaria, diarrheal diseases and polio, respiratory tract infections and meningitis, HPV and vector-borne viral diseases, as well as in the cross-cutting area of Maternal Immunization.
The CMC Quality Manager will be responsible for overseeing GMP manufacturing, tech transfer, and related activities. The CMC Quality Manager will report to the Associate Director of CMC Quality and work with other Quality counterparts as well as the CVIA Clinical, Regulatory, and Drug Development teams, providing leadership in addressing CMC Quality needs. This position will provide backup support to the Associate Director of CMC Quality and the Senior CMC Auditor.

Responsibilities:

Lead the development of data management (DM) strategies (e.g. use of central DM vendors, transition to Risk Based Monitoring) and the establishment of data management standards (e.g. SOPs, standard CRFs, and adoption/adaptation of CDASH/CDISC standards) for CVIA and potentially other groups within PATH.

Work with CROs and other partners to develop, implement, and successfully complete clinical study data capture and its summarization. Audit and qualify vendors, as necessary.

Closely oversee the activities of CROs during the implementation of all studies, providing technical oversight as the Project Officer for their corresponding contracts.

Play an active role in multi-disciplinary project and study teams by supporting all DM activities in all phases of projects related to clinical development programs.

Bachelor's or Master's degree in a related field. Ten years of experience in supporting clinical research, including industry experience in various phases of vaccine research, supporting US and international trials. Advanced knowledge of DM and clinical trial methodology.

Ability to work on multiple projects simultaneously, with flexibility to work both collaboratively and independently in a multidisciplinary project environment.

Strong oral and written communication skills.

Ability to multi-task and effectively prioritize work and projects.

Willingness to travel within the US and abroad (up to 20% of the time).

Must have legal authorization to work in the United States.

PATH is dedicated to building an inclusive workforce where diversity is valued.

PATH is an equal opportunity employer. Every qualified applicant will be considered for employment. PATH does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, genetic information, age, national origin, marital status, disability status, political ideology, military or protected veteran status, or any other characteristic protected by applicable federal, state, or local law.